Investigation of Dietary Nitrate Optimisation by hyperuricaemia stratification in Heart Failure.
Disease area: Heart Failure
Status: Actively recruiting
Chief Investigator: Professor Amrita Ahluwalia
Lead Investigator: Dr Christopher Primus
Principal Investigators: Dr Simon Woldman, Dr Ceri Davies
Sponsor: Queen Mary University of London
Funder: The Derek Willoughby Fund for Inflammatory Research and Barts Charity
NCT Ref: ClinicalTrials.gov Identifier: NCT03511248
In the UK, around 900,000 people suffer with heart failure. Research groups are continuously working to identify new therapies that might improve overall health in patients with heart failure. These are in addition to the best medical treatment that your heart failure doctors prescribe you in clinic.
Nitric oxide is a substance normally produced by healthy blood vessels that plays an important part in maintaining blood vessel health. In patients with weak hearts, research has shown that the blood vessels are less able to make nitric oxide. Your doctors may well have used nitrates in tablet form to try and address this, with the aim of improving your symptoms and heart-related health. However, some patients develop tolerance to this type of drug and it does not address the underlying problem with the blood vessels themselves.
We know that diets rich in fruit and vegetables reduce the risk of blood vessel related disease, including heart attacks and stroke. Many vegetables, particularly green leafy vegetables and beetroot, are rich sources of dietary nitrate. Our recent research has shown that consuming this inorganic dietary nitrate results in more nitric oxide being produced in the body. This has been shown to be safe in healthy volunteers, as well as having benefit in patients with high blood pressure, high cholesterol and those having heart attacks.
We therefore want to investigate whether these positive effects translate to benefits for patients with heart failure. This is through taking a once daily dose of beetroot juice, which has high levels of inorganic nitrate.
The test substance is dietary inorganic nitrate in the form of beetroot juice. Inorganic nitrate is present in food, especially in vegetables, and we also produce it ourselves in our body. We are able to transform inorganic nitrate to inorganic nitrite in our mouths. Once this is absorbed in our gut, our bodies further metabolise this to nitric oxide.
This beneficial substance, inorganic nitrate, is found in high concentrations within vegetables such as beetroot, as well as lettuce and cabbage.
Our aim is to test a commercially available beetroot juice, that is rich in this dietary nitrate, to identify positive benefits in patients with heart failure. Half of the patients recruited will receive a placebo-juice, that looks and tastes the same, but the nitrate has been removed by the same process that is used to remove nitrate from our drinking water in the UK.
In total there will be four visits for the study over a period of 12 weeks and 6 monthly follow-ups for 3 years. Following completion of the study the patient returns to the normal care of their heart failure team. The patient is contacted by telephone at 6 and 12 months after completion of the study to re-explore their heart failure symptoms and discuss relevant aspects of their medical care over that period of time.
Sample size and duration
92 patients recruited over 2 years.
For further information on this study, please contact:
Dr Christopher Primus